A cost effectiveness of the PACE trial

This further publicity push is political in that it coincides with the migration of long-term benefit claimants onto a new benefit, one that is harder to qualify for.

It is all about massaging the public perception of the long term sick and cutting costs.

Unfortunately all this garbage still needs to be intellectually refuted. I admire those who can give their energy to constructing rational arguments against this evil rubbish. I get too angry to be able to think about it much, but PACE is going to be used as "evidence" against claimants, I am sure.

Spun headlines: CBT and GET are the most cost-effective and should become standard offerings.

Frank assessment: CBT and GET are essentially useless for reducing overall service costs and employment losses, fail to prevent the increased use of welfare benefits and other financial payments.

About time, it took nearly 18 months after the 1st publication! At BACME 2012, White highlighted the supposed irony in patient organizations' comments about how the PACE findings that CBT/GET are safe and effective was "bad news for patients". Similarly, although I can understand why people are disheartened about how the latest PACE results are being presented, this new paper is partly "good news for patients" for the following reason:

CBT or GET do very little to prevent loss of employment hours and do not significantly help get people off welfare and insurance benefits etc, or prevent people from getting these in the first place. Coincidently, out of the BBC article, the MRC press release, the Independent article, and numerous other articles parroting the same content, suspiciously none of them mention these failed outcomes, so it makes me wonder why not. Despite the spin in the above mentioned news articles about the success and cost-effectiveness of CBT and GET, I doubt the relevant authorities will be motivated much to invest in a major roll-out of CBT/GET just because of cost-effectiveness analyses based on small improvements in self-reported symptoms and quality of life which are largely contradicted by objective measures. Since when did these authorities give a flying toss about our quality of life anyway? Their main interest was getting people off disability/insurance payments and back into work, and this isn't really happening. So they cannot look to the PACE Trial for an excuse to start disingenuously "cracking down" on payments or forcing people into CBT/GET before getting payments. If the PACE Trial demonstrated clear benefits for employment/disability outcomes, which it frankly did not, the implications for patients on such payments would have been much different and this would have been featured in the headlines instead.

The data from Table 3 and Table 4 and Table 5 is sobering, total societal costs remain high and are barely reduced by CBT and GET vs SMC before even accounting for the extra cost of CBT and GET infrastructure and sessions. Overall there is no obvious advantage for CBT and GET in total service costs. Perhaps they emphasized the QOL/symptom based analyses to distract away from these otherwise disappointing results. These therapies are only "cost-effective" because, although they don't do much to reduce overall costs, they are relatively very cheap compared to the costs being incurred due to CFS. Consider the following crude analogy:

For treating CFS, there is no such thing as high quality candy (reasonably effective treatment). We do however have very cheap candy (CBT/GET) which a small proportion of patients find tastes slightly more pleasant (small improvement in subjective measures) than plain chalk bread (SMC). Therefore, enough very cheap candy for enough people will generate the same amount of taste goodness as high quality candy and at a reasonable cost too, therefore, very cheap candy is "cost-effective" at producing pleasant taste even if most patients do not like the taste better than plain chalk bread. Studies by candy proponents invested in promoting or selling candy report that patients do not dislike the taste (adverse effects), although external surveys of candy eaters suggest that many indeed dislike the taste. Candy proponents claim that there is nothing wrong with the candy and the people that don't like it aren't eating it properly.

Despite the spin this is overall bad news for PACE, they had a "soft" win (cost-effectiveness based on QOL) but a "hard" loss (poor employment/disability/insurance outcomes). These results are unsurprising, but I was sort of expecting a small effect, either because of a genuine but small effect on Oxford criteria patients, or because the milder affected or borderline-disability cases in the trial could at least be encouraged to delay their application for benefits or temporarily reduce them at least during the course of the trial. Good work to those already questioning how the cost-effectiveness was calculated and how such measures could be biased.

Another point to consider is that despite the increasing welfare/insurance payments to CBT participants over the course of the trial, the [Work and social adjustment scale] in the 2011 Lancet paper was the only secondary measure where CBT reached the authors definition of clinically useful difference (0.5SD of baseline scores). This scale is described in the 2007 protocol as a "comprehensive measure of participation in occupational and domestic activities", and IIRC Chalder has even published a paper validating its use for CFS. So one wonders what is actually being measured there.

In one of his presentations, White seemingly made out that the Ross et al 2004 paper showed CBT/GET was effective at "restoring the ability to work", although the actual data behind the statement was weak upon further investigation. They are going to have trouble spinning the latest results in their favour, and probably would have done so already if possible, that explains why employment/disability data was buried in the paper as lesser importance (they were obliged to report it eventually). IIRC they did not even factor these payouts into the cost analysis! Now we just need the data on recovery, other secondary outcomes, and mediating factors, so we can see how much the house of cards has fallen.

It is no surprise that only several days ago, the MRC announced additional funding for other research, in addition to the announcement late last year after much drought. This change and the PACE Trial itself may mark the beginning of the end for the cognitive behavioural "model" of CFS, although previous data already made it look unstable.

But maybe I've just been kidding myself that the truth would out in the end.
This sort of rubbish coming from the BBC has a danger of turning me into a militant patient which, ironically, would only help prove that Wessely's portrayal of ME patients is correct!

Haven't the BBC heard from us all enough to avoid regurgitating the stuff that comes from the PACE Trial authors? (Clearly not.)
The article feels like a deeply insulting slap in the face.

And how do the psychiatric lobby manage it? Where do they get their resources from, in order to manage this sort of slick publicity so supremely? Is it public funding?
We've all been trying for a year and a half to get one single journalist to expose the PACE Trial for what it is, but have failed. Whereas the psychiatric lobby manage to cover the news media with articles, within one day of publishing their latest scam.

Does anyone know the phone number to the BBC news desk? I'm in the mood for talking to the team who put this on the website.

It's one thing to have the psychiatrists persistently secreting their misinformation, but when the media conspires with them, it really feels tough.

I'm feeling really insulted by all of this, and a little defeated,

Bob

PS: I haven't read any of the actual paper yet.

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Having run a technology based competition with where we got a lot of press coverage in media it seems to me that the media don't think about the story. They like simple sound bites they don't really read stuff.

Hence a well timed press release (with credibility around where it comes from) along with a series of interviews where the journalists get an explanation and perhaps ask about one or two media friendly points.

... That their patients have ended up less able to work and more dependent on benefits from the state would seem to indicate that their therapies aren't a colossal success.

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. Actually, it does appear that employment lost decreased for all groups (nb the second lot of data is for 12 months vs 6 months for the initial data) and GET the most (13% fall vs 6% for SMC) but presumably the differences were not significant as the paper says "There was no clear difference between treatments in terms of lost employment".

How can they say that any of their treatments are cost effective when they've got no control group?

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That's a very good point, we dont know how a 'no treatment' group would have fared. Interestingly, the first sentence of the Method does call PACE a randomised controlled trial, while the main PACE paper was notable for never using the word 'control'. Nb the comparisons of GET & CBT vs SMC would still hold.

One important thing would be whether they examined whether their missing data was more likely to be from those patients who stopped therapy. If those patients finding a particular treatment unhelpful were most likely to stop, then this could have a dramatic impact on improving reported cost effectiveness as them stopping treatment would lower the average cost of treatment, and their missing data could also be filled in with data from those patients who found the treatment more helpful, kept at it, and filled in forms at the end.

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nb this from the final 'Limitations' para

...we analysed data only for those
participants where we had data at both baseline and follow-up.
This may have introduced some distortions to the results but therewere few differences between patients with missing data and thoseon whom we had complete data.

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Though of course it would be good to know what exactly those differences were, I'm surprised they didn't mention it.

. Actually, it does appear that employment lost decreased for all groups (nb the second lot of data is for 12 months vs 6 months for the initial data) and GET the most (13% fall vs 6% for SMC) but presumably the differences were not significant as the paper says "There was no clear difference between treatments in terms of lost employment".

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Did I misread that too? I could tell I was not up to much last night (or today tbh). I deserve a not a !

'Overall, this is important research into a disabling illness. CFS can last for years. It affects between 0.2 and 2.6% of people worldwide and can be highly disruptive to employment and family life. Any treatments that can be proven to help will most likely be welcomed by those affected by the condition'

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Even the NICE Guidelines cite a prevalence of 0.2-0.4% The above may well be present in the PACE Trial or the paper published above (haven't read it yet), but based on 0.2-2.6% (Reeves if I'm not mistaken) then does this not further confirm that they are applying rather a broad definition? Hardly surprising therefore that they can claim cost-effectiveness i.e. there's a far greater chance I would suggest (have suggested) of a more positive response for those at the broader end of the spectrum.

'Overall, this is important research into a disabling illness. CFS can last for years. It affects between0.2 and 2.6% of people worldwide and can be highly disruptive to employment and family life. Any treatments that can be proven to help will most likely be welcomed by those affected by the condition'

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Even the NICE Guidelines cite a prevalence of 0.2-0.4% The above may well be present in the PACE Trial or the paper published above (haven't read it yet), but based on 0.2-2.6% (Reeves if I'm not mistaken) then does this not further confirm that they are applying rather a broad definition?

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I'm pretty sure it's actually Simon Wessely's prevalence rate for Fukuda-defined CFS ie 1 in 40. I'm surprised that a man with a PhD in epidemiology would publish such an unlikely figure but it happened. If you read the thread you will see there were some questionable methodology, including carrying out the fieldwork in the years before Fukuda was published, not doing all the lab tests, not doing a full medical history and examination and using an unpublished unvalidated questionnaire for diagnosis. The CMO's medical report, published not that long after, chose to go with an estimate of 0.4% instead.

Spun headlines: CBT and GET are the most cost-effective and should become standard offerings.

Frank assessment: CBT and GET do not prevent employment losses, welfare benefits, or insurance payouts.

...although I can understand why people are disheartened about how the latest PACE results are being presented, this new paper is partly "good news for patients" for the following reason:

...Despite the spin in the above mentioned news articles about the success and cost-effectiveness of CBT and GET, I doubt the relevant authorities will be motivated much to invest in a major roll-out of CBT/GET just because of small increases in self-reported quality of life based on subjective measures which are contradicted by objective measures. Since when did these authorities give a flying toss about our quality of life? Their main interest was getting people off disability/insurance payments and back into work, and this isn't happening. So they cannot look to the PACE Trial for an excuse to start disingenuously "cracking down" on payments or forcing people into CBT/GET before getting payments.

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That's a hugely significant point. I think PACE was the first clinical trial ever co-funded by DWP (Department for Work and Pensions) and were presumably doing so as they thought it would lead to significant improvements and get people with CFS off benefits. The evidence is that it doesn't. That's a shame as I would have been delighted if CBT & GET really worked giving real-world outcomes like more people being able to work and fewer needing benefits.

The Biopsychosocial approach to medicine is a major driving force in the recent UK benefit reforms, which are currently pushing lots of ill and disabled people in to poverty, and saving the Government lots of money.

One of the quotes I pulled out was this:

The major limitation of the biopsychosocial approach has been the lack of simple
clinical tools to assess psychosocial issues and simple, practical interventions to address
them (Kendall et al 1997, Borkan et al 2002, Kendall & Burton 2009). After more than
30 years, and despite agreement on the importance of psychosocial factors, there is
relatively little empirical evidence for effective biopsychosocial interventions at an individual
level. The challenge is to develop simple, practical, biopsychosocial messages for
routine practice, and the evidence base for their effectiveness.28

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This lack of evidence is rather important.

PACE is the only piece of medical research which the DWP has funded, and I think that it's important to see it in the context of recent benefits reforms, and a desire for evidence to support a BPS model of disability which could be used as an excuse to shift responsibility for disability away from society, and back on to the individual.

There is also quite a lot of public cynicism about government and 'expert' claims about the recent benefit reforms, as lots of people know individuals personally affected, and can see the disconnect between the claims being made and reality. If we were able to show the connection with the way in which CFS is being treated in the UK, it could help us overcome people's instinctive deference to the government and 'experts'.

The Biopsychosocial approach to medicine is a major driving force in the recent UK benefit reforms, which are currently pushing lots of ill and disabled people in to poverty, and saving the Government lots of money.

One of the quotes I pulled out was this:

This lack of evidence is rather important.

PACE is the only piece of medical research which the DWP has funded, and I think that it's important to see it in the context of recent benefits reforms, and a desire for evidence to support a BPS model of disability which could be used as an excuse to shift responsibility for disability away from society, and back on to the individual.

There is also quite a lot of public cynicism about government and 'expert' claims about the recent benefit reforms, as lots of people know individuals personally affected, and can see the disconnect between the claims being made and reality. If we were able to show the connection with the way in which CFS is being treated in the UK, it could help us overcome people's instinctive deference to the government and 'experts'.

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I think the DWP funding PACE was a vanity funding thing from Aylward. Something to help prove his theories correct.

I would separate this out from recent efforts from the government to cut disability benefits. I think the current government see disabled people as an easy target hence with appropriate news stories they can save a bit of money. However today there seems to be some movement on the WCA.

Their main interest was getting people off disability/insurance payments and back into work, and this isn't happening. So they cannot look to the PACE Trial for an excuse to start disingenuously "cracking down" on payments or forcing people into CBT/GET before getting payments.

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Thanks biophile, for bringing a bit of perspective to it all. You've made me feel a bit better. I think your quote, above, is very interesting. I wonder if private insurance companies will take notice of this as well, and will stop being so keen on pushing CBT.

If they want to improve quality of life at low cost, I still think my suggestion of regular gift baskets to all ME patients, or better yet gift vouchers, would be much more cost effective. If they were serious about improving real outcomes we would be seeing CBT and GET compared with pacing (not APT), antivirals and immune modulators. It would come up a total failure in a fair comparison, not the carefully disguised failure it is now. Bye, Alex

The combined proportion of participants receiving all types of financial payments increased in all groups was SMC 37%-60%, APT 50%-68%, CBT 48%-63%, GET 53%-72%. The authors write that "However, with the exception of a difference between CBT and APT, there were no significant differences in either lost work time or benefits between the treatments during follow up. In fact, benefits increased across all four treatments." Obviously a genuine improvement in employment outcomes without other consequences would/should be welcomed by patients, but PACE couldn't even demonstrate a superficial one, and who would have believed PACE when considering the patient cohort, trial methodology, and authors' potential COI or staunch pro-CBT/GET stance?

It would be ironic for the underlying rationale of CBT/GET if much of the "improvement" in the primary and secondary measures of the PACE Trial were due to more participants getting financial payments and therefore being able to restructure their lives. What about the limited research suggesting that receipt of financial payments at baseline "predicts" worse outcomes? IIRC, the research assumes correlation is causation, and baseline measurements do not account for those that start receiving payments during a trial. It would be unsurprising if those already in receipt of payments at baseline were less likely to respond to CBT/GET. Although "receipt of ill-health benefits or pension" is listed in the 2007 protocol as one of the predictors to be evaluated in the PACE Trial, no papers has been published on the issue, and you can guarantee PACE would have already presented the data if an association was demonstrated.

In the first PACE paper, it was possible to enter the trial with 'disabling fatigue', make no improvement or even decline a little, then be classed as being within 'normal range' after 12 months, which was cleverly spun as a success and even misrepresented by others (including the Lancet editorial) as 'recovery'. One wonders if this recent cost-effectiveness analysis is a similar stunt or diversion?

I'm glad you feel slightly better after my last post, Bob. On another thread, currer suggested that I cheer up about the general research situation because of the boost XMRV/MLV research gave to the profile of ME/CFS, and I replied that I'm uncertain about how much of a boost there is and although things are improving they are taking too long. However, I guess part of me does feel slightly better too now after the recent 2nd PACE results paper (and the recent MRC announcement of more funding), because it is further evidence that the relevant authorities' previous approach of ignoring ME/CFS and hoping it goes away or can be patched up with cheap CBT/GET is not working. As CBT/GET will not help the UK's welfare problem or do much to reduce their health-care costs, it must now be blatantly obvious to these authorities (in private behind the scenes of public relations and spin doctoring of course), that there has to be another approach, ie actual biomedical research. Without taking such action, the problem is only going to continue.

What happens when you multiply 63 million people by a prevalence of 2.6% by twenty one thousand pounds? :wink:
Now there is a fact worthy of a media report!

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Morning,

Absolutely and if you recall that's exactly what (if I remember correctly) Crawley's team did with that economic loss report last year (earlier this year?). I mean if they want to play fair then this 'cost-effectiveness' has to be realistically built in to the NICE model for costings of a service. The costing report is here (2007): http://www.nice.org.uk/nicemedia/live/11824/36203/36203.pdf These new figures from yesterday will impact on that I would suggest especially if the estimated number of sessions with a specialist/therapist has been increased. I mean hell, the people in the PACE Trial were 'therapized' for a long time. Apply THAT to the real world and I can't see it as being as 'cost effective' as the term should mean

Edit:

I have yet to read it but how about this for a headline exemplifying what I was saying above:New recommendations for treating fatigue could save economy millions